Often connected to the successful implementation of clinical trials, which evaluate the safety and effectiveness of pharmaceuticals, medical devices or in-vitro diagnostic devices, clinical data managers are responsible for all aspects of data collection and dissemination. These professionals commonly lead the decision-making processes to determine which data collection methods and tools should be utilized in clinical trials.
While this position can include a large number of technical tasks, project management may also be a sizable component of this role, which is why interested individuals should ensure they have the right combination of education, experience and practical skills before applying for clinical data manager jobs.
Offering a varied curriculum that touches on many of the important proficiencies a clinical data manager should possess, a Master of Science in Information Technology may begin with core courses that cover advanced IT principles followed by an elective area of focus. For those thinking about a career as a clinical data manager, elective courses in information systems management and systems development may help to improve students’ relevant technical skills while increasing their expertise in today’s cyber system infrastructure.
What's the job description of a clinical data manager?
The tasks a clinical data manager may have to accomplish on an average day depend on the current stage of a clinical trial, whether it be before, during or after.
A lot of preparation can go into ensuring clinical trials are properly set up to collect, organize and manage incoming data, and a clinical data manager is responsible for overseeing and coordinating these processes. Before a specific strategy can be designed, it’s important that these professionals understand the relevant systems to implement best practices and utilize new IT developments. Several specific tasks may be necessary to prepare for a clinical trial, including:
- Creating technical specifications for data management programs to share with IT staff and involved departments.
- Designing and validating clinical databases.
- Developing data management plans in areas such as coding, reporting, workflow or data transfer.
- Resolving problems with databases.
- Selecting which, if any, electronic data capture system to use to make long-term data collection more efficient.
- Training participating staff on technical procedures or software usage.
During a trial, clinical data managers can be responsible for leading the team that manages how data is collected and validated. They must ensure the trial meets all requirements throughout this stage and adheres to protocols established by institutional review boards or regulatory agencies if applicable. They may also have to troubleshoot system installation issues or ongoing system maintenance as data collection happens.
If you are working as a clinical data manager at a large organization, the typical tasks you’d be in charge of after a clinical study may stop once you’ve delivered the data to a statistical team for analysis. However, if you’re working at a smaller company, you might need to conduct the data analysis yourself. If that’s the case, some tasks you may encounter at this stage include identifying and reporting on data trends and sharing results with key stakeholders.